A Study in Radiotherapy-related Nervous System Complications
NCT ID: NCT03908502
Last Updated: 2023-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
4000 participants
OBSERVATIONAL
2017-06-01
2037-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
OUTLINE: This is an observational clinical trial. Patients are enrolled and administrated with optimized clinical treatment. Blood, urine, stool, cerebrospinal fluid (CSF), imaging and other examinations, and scale assessments are regularly performed to evaluate the state of the disease.
Further study details are provided by Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University/Yamei Tang.
Primary outcome measure: The primary endpoint is overall survival.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Single-center Observational Clinical Trial of Stereotactic Radiotherapy on Metastatic Spinal Tumors Using TomoTherapy
NCT05808998
Radiation Therapy in Preventing Central Nervous System (CNS) Metastases in Patients With Non-Small Cell Lung Cancer
NCT00048997
Fractionated Stereotactic Radiotherapy vs. Single Session Radiosurgery in Patients With Larger Brain Metastases
NCT03697343
Tomotherapy for Leptomeningeal Metastases
NCT04178343
Local Treatment for Bone Metastases
NCT05665439
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Radiotherapy is a key component in the management of head and neck tumors and primary or metastatic cancer of the central nervous system. Various radiation treatment methods employ different types of fractionation and conformational protocols designed to deliver focused radiation to target regions to maximize the lethal effect on the neoplasm and minimize the extraneous dose on normal brain tissue and other adjacent organs at risk. The outcomes of these clinical protocols may be complicated by radiation effects on normal brain parenchyma and other nervous system, resulting in a spectrum of phenotypes that range from clinically asymptomatic changes to radiotherapy-related nervous system complications with severe neurological defects, including delayed radiation-induced brain necrosis, myelopathy and nerve injury.
STUDY DESIGN:
Interventions Patients are enrolled and administrated with optimized clinical treatment.
Follow-up examinations
1. Blood, urine and stool examinations, such as biochemical A, coagulation routine, thyroid function, EB virus DNA, erythrocyte sedimentation rate, morning cortisol, urine sodium and potassium, gonadal hormone, growth hormone, glycosylated hemoglobin.
2. Imaging examinations, such as MR, CT, ultrasound. X ray is performed if needed.
3. Other examinations, such as pure tone audiometry, fundus exam, visual exam, VEP, OCTA, visual field exam.
4. Scale assessments about neurological function, radiation injury, common psychiatric disorders, cognitive function, quality of life, drug side effect, sleep and pain, such as LENT/SOMA, WHO-QOL, MoCA, MMSE, Hamilton anxiety scale, Hamilton depression scale, Pain numerical rating scale, Drug side effect scale, ADAS-cog, fatigue self-assessment scale (FSAS), Neuropsychiatric Inventry (NPI) total score, Clinical Dementia Rating Scale, Barthel index, UPDRS, Self-Rating Scale of Sleep (SRSS), NCI-CTCAE, CIBIC-plus and SSA.
5. Blood sample are obtained in order to investigate significant genes, proteins and metabolites involved in the development and progress of radiotherapy-related nervous system complications. Genomics, metabolomics and proteomics are performed to detect potential genes, proteins and metabolites. Stool sample are obtained in order to investigate interactions between the gut microbiota, immune and nervous systems in radiotherapy-related nervous system complications. Cerebrospinal fluid (CSF) and biopsy samples are obtained if needed.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
0 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yamei Tang
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yamei Tang, M.D., PhD.
Role: STUDY_DIRECTOR
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yamei Tang, M.D., PhD.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Li H, Rong X, Hu W, Yang Y, Lei M, Wen W, Yue Z, Huang X, Chua MLK, Li Y, Cai J, He L, Pan D, Cheng J, Pi Y, Xue R, Xu Y, Tang Y. Bevacizumab Combined with Corticosteroids Does Not Improve the Clinical Outcome of Nasopharyngeal Carcinoma Patients With Radiation-Induced Brain Necrosis. Front Oncol. 2021 Sep 28;11:746941. doi: 10.3389/fonc.2021.746941. eCollection 2021.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
20170601001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.